Ustekinumab
STELARA
Pronunciation: us-te-KIN-yoo-mab
What it isIL-12/23 p40 monoclonal antibody; psoriasis, psoriatic arthritis, Crohn disease, and ulcerative colitis.
Why this oneFor psoriasis/PsA, it offers quarterly maintenance dosing, but skin clearance trails newer selective IL-23 and IL-17 agents.
What limits itScreen for infection and tuberculosis before treatment; serious infection and injection reactions can occur.
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Plaque psoriasis (SC) | Adults | ≤100 kg: 45 mg SC at wk0 and wk4, then q12w; >100 kg: 90 mg SC at wk0 and wk4, then q12w | q12w maintenance | 90 mg q12w |
| Plaque psoriasis (SC) | Pediatric ≥6 y | <60 kg: 0.75 mg/kg; 60–100 kg: 45 mg; >100 kg: 90 mg — at wk0 and wk4, then q12w | q12w | 90 mg q12w |
| Psoriatic arthritis (SC) | Adults | 45 mg SC at wk0 and wk4, then q12w (90 mg if coexistent plaque psoriasis and >100 kg) | q12w | 90 mg q12w |
| Psoriatic arthritis (SC) | Pediatric ≥6 y | <60 kg: 0.75 mg/kg; ≥60 kg: 45 mg (90 mg if >100 kg with coexistent plaque psoriasis) — wk0, wk4, then q12w | q12w | 90 mg q12w |
| Crohn's disease | Adults | Single weight-based IV induction (≤55 kg 260 mg; >55–85 kg 390 mg; >85 kg 520 mg) | 90 mg SC 8 wk after IV, then q8w | 90 mg q8w |
| Crohn's disease | Pediatric ≥10 kg | IV induction (10–25 kg 10 mg/kg; >25–55 kg 260 mg; >55–85 kg 390 mg; >85 kg 520 mg) | Maintenance: 10–35 kg 2.5 mg/kg SC; >35 kg 90 mg SC — 8 wk after IV, then q8w | 90 mg q8w |
| Ulcerative colitis | Adults | Single weight-based IV induction (≤55 kg 260 mg; >55–85 kg 390 mg; >85 kg 520 mg) | 90 mg SC 8 wk after IV, then q8w | 90 mg q8w |
| Ulcerative colitis | Pediatric ≥10 kg | IV induction (10–25 kg 10 mg/kg; >25–55 kg 260 mg; >55–85 kg 390 mg; >85 kg 520 mg) | Maintenance: 10–35 kg 2.5 mg/kg SC; >35 kg 90 mg SC — 8 wk after IV, then q8w | 90 mg q8w |
Renal Undefined
Hepatic Undefined
Crohn's/UC: IV induction then SC maintenance q8w
Instructions
- SC injection (psoriasis, PsA, and all maintenance); IV infusion for Crohn's/ulcerative colitis induction only
- IV induction infused over ≥1 hour using a 0.2 micron in-line filter
- Rotate SC injection sites
- Prefilled syringe needle cover contains latex
- Determine dose by current body weight
Available strengths
- inj 90 mg/mL
Cautions
- Infections (serious bacterial, fungal, viral); screen for TB before starting
- Malignancies
- Serious hypersensitivity reactions
- Posterior reversible encephalopathy syndrome (PRES)
- Noninfectious pneumonia
- Complete needed vaccinations; avoid BCG around treatment
Adverse reactions
- Nasopharyngitis
- Upper respiratory tract infection
- Headache
- Fatigue
- Injection site erythema
- Vomiting (Crohn's induction)
Pregnancy No identified drug-associated risk of major birth defects/miscarriage; monoclonal antibody crosses placenta
Lactation Present in human milk; no adverse effects on breastfed infant identified
Cost
| Strength | #/mo | generic $/unit | CostPlus | |
|---|---|---|---|---|
| 90 mg/mL | inj | per unit | $3417.43/mL | offered |
NO BOXED WARNINGS
Principal riskInfections, including tuberculosis
Classes and tags
Clinical profile
Legacy pregnancy categoryB
Defining liabilitySerious infection and hypersensitivity